TWI600438B - Method of hydrogel sheet for wound - Google Patents

Description

Method for utilizing wound hydrogel sheets

The present invention relates to a skin wound affected area which is considered to be a concomitant infectious disease, or which is considered to be in a state of extreme infection with an infection or a bacterial colony, even if it is not yet infected, and has a function of removing a biofilm formed by bacteria and self-infecting wounds. The effect of removing bacteria and/or inhibiting the growth and development of bacteria that are expected to have wounds of infection, and the absorption of exudates and the like to prevent infections such as maceration or bacteria of healthy skin containing wound edges, and at the same time, excellent by the wounds The water-adjustability, the wound bed environment is adjusted, and the follow-up and stretchability are excellent, and the self-adhesive property can be avoided, and the wound hydrogel sheet and the utilization method thereof can be avoided by avoiding pain during exchange or re-injury of the regenerated skin.

In addition, the wound hydrogel sheet attached to the wound is removed from the affected area such as a wound, and the inactive tissue, the molting or the biofilm is removed, the infection is suppressed, the wound bed environment is adjusted, and the like, and the wound bed environment is adjusted to effectively improve the wound bed environment. A method of treating wounds in a wound healing environment.

The so-called wound bed environment adjustment (Woster bed preparation) adjusts the wound bed environment to promote wound healing, specifically, removing necrotic tissue, reducing bacterial burden, preventing wound drying, controlling excessive exudate or wound edge management.

The healing process of trauma is generally performed by (1) bleeding clotting period, (2) inflammatory phase, (3) proliferative phase, and (4) maturation phase. (1) bleeding clotting phase is stopped by coagulation factor or platelet, and platelet A proliferative factor ‧ cytokine such as a platelet-derived proliferation factor is released. Next, (2) the inflammatory phase causes infiltration of inflammatory cells such as neutrophils or macrophage, and phagocytosis of necrotic tissue to cleanse the wound. At the same time, it can be seen that the cells further continuously release the proliferation factor ‧ cytokines such as transforming growth factor-β (TGF-β) or fibroblast growth factor (FGF). In addition, in order to melt necrotic tissue proteins, proteases such as matrix metalloproteinase (MMP) are also released. As the wound is cleaned, it moves to the (3) proliferative phase. (2) The factors released in the stage promote the movement and proliferation of fibroblasts or keratinocytes. The extracellular matrix represented by collagen is synthesized from fibroblasts, and becomes a basis for cell migration, bonding, and the like. In addition, angiogenesis, granulation tissue mixed with various cells such as neovascularization and fibroblasts, and extracellular matrices such as collagen are also filled with tissue-defective sites. The wound covered with good granulation is further epithelialized by the movement of keratinocytes, and the wound area is gradually reduced by the two mechanisms of wound contraction of myofibroblasts. As a result, the wound closure becomes (4) maturity and the formation of scar tissue. By the mechanism of remodeling of the extracellular matrix, the initial reddish marks become white and soft and mature after several months of whitening. Chronic injury refers to the occurrence of any one of (1) to (4), delaying the cure, but it can be seen as (2) long-term and chronic inflammatory phase, that is, (2) the disorder to (3). At the molecular and cellular levels, it is considered that this chronic inflammatory state is associated with a combination of cell abnormalities, abnormal exudates, or abnormalities of extracellular matrix. Therefore, in order to break away from chronic inflammation and rapidly move to the healing stage of the (3) proliferative phase, it is necessary to adjust the wound bed environment.

If the wound bed environment is not adjusted and the cure is not carried out, the skin wounds will cause inflammation or infection when the residual foreign matter remains. The residual necrotic tissue will store the exudate under the wound, forming an abscess, and it is difficult to assess the depth of the actual wound. Therefore, the implementation of debridement is directly related to the management of exudates and the control of infection.

Biofilms and the like which are present in inactive tissues or defective granules, tissues that are affected by disorders, severe colonic growth (in the initial state of inflammation, and the initial state of inflammation of the biological immune response) are deeply involved in the delay of healing. Therefore, it is known that wiping wounds, removing necrotic tissue, removing exudate, removing bad granulation, removing biofilm, etc., are important for the healing process of wounds or skin diseases, especially for wiping wounds, removing necrotic tissue and A hydrogel or an ointment or the like can be used to remove bad granulation and the like.

The conventional flaky hydrogel (PVA hydrogel, etc.) preparation contains a large amount of purified water, and is used for self-melting action such as softening of necrotic tissue or the like, but it is difficult to be self-adhesive and stretchable. When it is used for a curved portion or an extensible portion, the water absorption is low, so that the exudate or the like accumulates, and there is a disadvantage that the healthy skin including the wound edge is soaked (Patent Document 1).

Regarding the gel-like hydrogel, it is particularly effective for the treatment of a capsular bag to form a wound or the like, but there may be a disadvantage of surgical debridement or the like when it is removed.

For ointments, use a blended proteolytic enzyme preparation [blend fradiomycin sulfate ‧ francetin, fradiomycin powder, trypsin (trypsin powder), blended Bromelain, blended streptokinase ‧ Streptodornase (Varidase) or fibrinolysin ‧ deoxyribonuclease (elase, elase-C) in the removal of necrotic tissue, etc., but caused by drug allergy or The skin around the skin is dermatitis or macerated, so it is necessary to protect the skin around the wound with Vaseline or the like.

In addition, one of the delay factors for wound healing is considered to be a biofilm formed by bacteria on the surface of the ulcer, but conventionally, although a disinfectant or an antibacterial external preparation has been used, it has been found that the disinfectant delays wound healing due to cytotoxicity. Antibacterial agents have disadvantages such as the occurrence of resistant bacteria.

On the other hand, after physical therapy (cryotherapy, laser therapy, phototherapy, ultrasound therapy, resection, etc.) or chemotherapy (salicylation of salicylic acid, monochloroacetic acid, glutaraldehyde, phenol, ethanol, etc.) After the removal of lesions or softening, treatment of skin cancer with a large amount of exudate or necrotic tissue, etc., generally used gauze, sponge, hydrocolloid, polyurethane, hydrogel, cotton, Other fiber materials and ointments.

In particular, breast cancer, breast cancer, skin metastases, and other malignant tumors in which the skin is exposed to the unresectable treatment are administered with an ointment having an antibacterial and anti-ulcer effect, or coated with gauze or other fibrous material. However, gauze or other fibrous materials absorb liquid by capillary action, but because the absorbed blood or exudate is dry, or these fibers are buried in the tissue, when the fibrous material is removed, the tissue is torn, and many pains occur. At the same time, bleeding occurred.

Conventional hydrogels or polyurethane films have the disadvantage of being soaked in the affected area and surrounding healthy skin because of low water absorption.

The water-gel system absorbs the exudate by swelling the hydrophilic colloidal particles contained in the hydrophobic base, but is liable to collapse due to water absorption, and the gel-like substance remains in the affected part during exchange. In addition, it is mostly translucent to opaque, it is difficult to observe the surface of the wound, and because of the strong adhesion, there is a lot of pain accompanying the exchange, and there is a tendency to cause peeling stimulation.

Although the polyurethane foam absorbs a large amount of exudate, it has the disadvantage that the affected area and the surrounding skin are easily soaked and infected when the exudate is administered with a large amount of exudate.

A self-adhesive polyurethane film, that is, a wound coating material coated with an acrylic adhesive on a urethane film, although excellent in stretchability, it is applied to almost no absorption. When the exudate leaks out of the wound surface, it is easy to cause liquid accumulation, so it is necessary to drain. In addition, since the adhesive force is also strong, not only the pain is exchanged, but also the skin that has regenerated the skin is damaged (Patent Documents 2, 3, and 4).

Although the alginate gel is excellent in hemostatic property and absorbability, it gels due to exudate. Therefore, the gelled substance is likely to remain on the surface of the wound during exchange, and since it is open, it is moisturized and prevents invasion and prevention of bacteria. Bacterial proliferation must be covered with a film material. (Patent Document 5)

According to the above, it is expected to have a self-adhesive property, a good stretchability, an exudate absorption property, a good moisturizing environment, a softening, removal of necrotic tissue or suede, and removal of a biofilm formed by bacteria, etc., and adjustment of the wound bed environment. A good wound hydrogel sheet.

[Previous Technical Literature]

[Patent Document 1] Patent No. 3773883

[Patent Document 2] JP-A-58-87153

[Patent Document 3] JP-A-4-272765

[Patent Document 4] JP-A-2006-61263

[Patent Document 5] JP-A-8-187280

The present invention solves the conventional problem and provides a good effect of removing the molting, necrotic tissue or the biofilm formed by the bacteria or inhibiting the number of bacteria in the wound site and adjusting the environment of the wound bed, etc., and the pain is not exchanged. Or a wound hydrogel sheet that damages the skin after regeneration and its utilization method.

In order to solve the above-mentioned problems, the inventors of the present invention have found that the hydrogel formed by coating a water-soluble polymer, glycerin, and water is formed of a polyurethane film and a hydrophobic fiber. a laminated film having a moisture permeability of 200 to 2000 (g/m ² /24h), and the wound hydrogel sheet is used to remove the skin, the necrotic tissue or the biofilm formed by the bacteria, and the adjusted wound of the exudate. The bed environment works well and the present invention is completed without pain or damage to the skin during exchange.

That is, the present invention is represented by the following types.

(1) A sheet for adjusting the wound bed environment of a skin wound affected area characterized by using a hydrogel sheet.

(2) In the sheet according to (1) above, the wound bed environment adjustment is a biofilm formed by bacteria which is removed from the skin wound site.

(3) In the sheet according to the above (1), the wound bed environment adjustment system removes bacteria from the wound wound and/or removes bacteria from the wound which is predicted to have an infection and/or inhibits bacterial growth and development.

(4) The sheet according to any one of the above (1) to (3), wherein the hydrogel sheet is coated with a hydrogel containing a water-soluble polymer, glycerin and water, and a polyurethane film and A hydrogel sheet formed by laminating two layers of a hydrophobic fiber and having a moisture permeability of 200 to 2000 (g/m ² /24 h).

(5) A method of treating a wound characterized by a wound bed environment in which a skin wound is affected by using a hydrogel sheet.

(6) A method for treating a wound described in the above (5), which is characterized by using a hydrogel sheet to remove a biofilm formed by bacteria in a skin wound site.

(7) A method for treating a wound according to the above (5), characterized in that the hydrogel sheet is used to remove bacteria from the wound and/or the bacteria are removed from the wound which is predicted to be infected, and/or the growth of the bacteria is inhibited.

(8) The method for treating a wound according to any one of the above (5), wherein the hydrogel sheet is coated with a hydrogel containing a water-soluble polymer, glycerin and water, and a polyaminocarbamic acid. A hydrogel sheet formed by laminating two layers of an ester film and a hydrophobic fiber, and having a moisture permeability of 200 to 2000 (g/m ² /24 h).

(9) Using a hydrogel sheet, a wound healing agent characterized by adjusting the environment of the wound bed is applied to the affected area of the skin wound.

(10) A wound healing agent according to the above (9), characterized in that the biofilm is used to remove a biofilm formed by bacteria in a skin wound site.

(11) A wound therapeutic agent according to the above (9), characterized in that the hydrogel sheet is used to remove bacteria from an infectious wound and/or to remove bacteria from an infected wound and/or to inhibit bacterial growth and development.

(12) The wound therapeutic agent according to any one of the above (9), wherein the hydrogel sheet is coated with a hydrogel containing a water-soluble polymer, glycerin and water in a polyurethane film. And a hydrogel sheet formed by laminating two layers of a hydrophobic fiber, and having a moisture permeability of 200 to 2000 (g/m ² /24h).

The wound hydrogel sheet of the present invention removes molting, necrotic tissue or defective granulation, and absorbs exudate. Further, it has the effect of removing the bacterial biofilm or bacteria of the wound surface or inhibiting the proliferation of the bacteria to adjust the wound bed environment to promote wound healing. On the other hand, the exudate is absorbed, a proper moist environment is maintained, and the skin of the wound is prevented from macerating. That is, the main use of the wound hydrogel sheet is to gently remove the wounded molting or necrotic tissue such as suede or necrotic tissue, gently remove the bacteria biofilm or infect the wound bacteria (antibacterial action), Proliferation of bacteria against acute trauma and by excretion of exudate from the surface of the wound from the vertical direction, so as not to weaken healthy skin containing the edge of the wound, maintain a proper moist environment, prevent obstacles or infections, and refine the wound, thereby making the wound bed Trauma management such as environmental adjustment becomes easy, and the wound can be cured. Further, the wound hydrogel sheet is also effective for removing physical diseases such as skin diseases and diseases after chemotherapeutic treatment. The related wound hydrogel sheets are usually attached to the wound by taking out from the bag, and can wipe the wound, remove the necrotic tissue, absorb the wound exudate, inhibit the infection, adjust the wound bed, and promote healing.

The best form for implementing the invention

The invention is illustrated in more detail below.

The hydrogel sheet of the present invention preferably has a moisture permeability of from 200 to 2,000 (g/m ² /24h), more preferably from 500 to 1,500 (g/m ² /24h). When the moisture permeability is less than 200 (g/m ² /24h), skin irritation due to stuffiness may occur, which is not suitable. Further, when it is more than 2000 (g/m ² /24h), it is not suitable to maintain the wound surface in a proper moist environment for a long time.

The polyurethane resin constituting the polyurethane film of the present invention can be a general polyurethane resin such as an ether system or an ester system, and is not particularly limited.

The polyurethane film used in the present invention has a thickness of 5 to 25 μm and a fixed load elongation of 5% or more.

When the thickness of the polyurethane film is less than 5 μm, the mechanical strength is insufficient and the pinhole is increased, and the wound surface cannot be maintained in a proper wet environment, which is not preferable. On the other hand, when it is thicker than 25 μm, the fixed load elongation is less than 5%, and the stretchability is impaired, so that it is difficult to protect the wound surface. In addition, since the transparency is also lowered, it is not suitable to observe the wound surface.

As the hydrophobic fiber laminated to the polyurethane film, polyester, nylon, acrylic resin, polypropylene, polyethylene, or the like can be used.

The moisture permeability of the two-layer laminated film made of the polyurethane film and the hydrophobic fiber thus produced is a moist environment suitable for promoting healing of the wound surface for a long time, and is 200 to 5000 (g/m). ^It is preferably within the range of ² / 24h), preferably 300 to 3000 (g/m ² /24h). When the moisture permeability is more than 5000 (g/m ² /24h), the wet environment cannot be maintained for a long time, and the effect of healing the wound surface is lowered. In addition, when it is less than 200 (g/m ² /24h), skin irritation due to stuffiness may occur, and it is not suitable.

As a water-soluble polymer, for example, gelatin, hydrolyzed gelatin, polyacrylic acid, sodium polyacrylate, polyacrylic acid partial neutralizer, polyacrylic acid starch, polyvinyl alcohol, polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl group Cellulose, hydroxyethyl cellulose, methyl cellulose, Carmellose Sodium, carboxyvinyl polymer, methoxyethylene maleic anhydride copolymer, N-ethylene acetamide copolymer Xanthan Gum, gum arabic, etc. may be used alone or in combination of two or more, but a combination of polyacrylic acid, a polyacrylic acid partial neutralizer, and sodium carboxymethylcellulose is particularly preferred.

The blending amount of the water-soluble polymer in the hydrogel sheet is 3 to 20% by weight based on the weight of the gel, and particularly preferably 5 to 15% by weight. When the blending amount is less than 3% by weight, the gel viscosity is too low, and it is difficult to form the adhesive as a patch. When it exceeds 20% by weight, the water-soluble polymer is not uniformly dissolved in the gel, and a good gel cannot be formed. So not suitable.

The blending amount of water in the hydrogel sheet is 30 to 80% by weight based on the weight of the gel, and particularly preferably 40 to 75% by weight. When the water content exceeds 80% by weight, the absorbability of the exudate is lowered, which is not preferable. In addition, when the weight is less than 30% by weight, the adhesive force becomes too strong, and when the wound coating material is exchanged, there is pain or damage to regenerate the skin, or because the moisturizing property against the skin is lowered, it becomes impossible to maintain a surface suitable for promoting wounds. It is not suitable for curing the moist environment.

Further, the blending amount of glycerin in the hydrogel is 10 to 40% by weight based on the weight of the gel, and particularly preferably 15 to 30% by weight. When the blending amount of glycerin in the hydrogel is less than 10% by weight, since the moisturizing property against the skin is lowered, it becomes impossible to maintain a moist environment suitable for promoting healing of the wound surface. When the amount of glycerin blended in the hydrogel is more than 40% by weight, glycerin which cannot be maintained on the surface of the gel may be released, and the problem of stickiness and adhesion at the time of attachment may occur.

The composition other than the above which constitutes the hydrogel sheet is not particularly limited, and for example, an excipient, a moisturizer, a stabilizer, a crosslinking agent, or the like can be blended.

As the excipient, for example, clay, titanium oxide, phthalic anhydride, zinc oxide, bentonite or the like may be used alone or in combination of two or more. However, when the hydrogel sheet is attached to the wound surface, the necessity of observing the wound surface due to the transparency of the hydrogel sheet is particularly preferable, and the blending amount is based on the gel weight. It is preferably 0.1 to 5% by weight.

The humectant other than glycerin, for example, D-sorbitol liquid, 1,3-butylene glycol, dipropylene glycol, polyvinyl alcohol, polypropylene glycol, sodium DL-pyrrolidone carboxylic acid, etc., may be used alone or in combination of two or more. The blending amount is preferably from 10 to 30% by weight based on the weight of the gel.

As the stabilizer, for example, ethylenediaminetetraacetate, p-hydroxybenzoic acid ester, tartaric acid, tocopheryl acetate, ascorbic acid, sodium hydrogen sulfite, or the like may be used alone or in combination of two or more. Further, the pH of the hydrogel sheet is preferably in the range of pH 3.5 to 6.5 from the viewpoint of skin irritation, and more preferably in the range of pH 4.0 to 5.5.

As the crosslinking agent, for example, a dry aluminum hydroxide gel, aluminum glycol aluminum fluoride, dihydroxyaluminum aminoacetate, synthetic hydrotalcite, aluminosilicate metal salt, and the like The valence metal compound or the like may be used alone or in combination of two or more. Although the blending amount varies depending on the type thereof, it is preferably 0.001 to 1% by weight based on the weight of the gel.

Further, a preservative, an antioxidant, a plasticizer, an emulsifier, a surfactant, or the like may be further blended as needed.

The hydrogel sheet of the present invention, when applied to a wound site, is required to follow a certain degree of adhesion of the skin action, and is required to be adhered without impairing the adhesion of the regenerated skin. Therefore, when the hydrogel sheet of the present invention is used (before water absorption), the adhesion is carried out in accordance with the Ball Tack test method of JIS Z0237, and the ball number in the ball test method at an inclination angle of 30° is 8 to 12. When the ball is exchanged (after 8 hours of water absorption), the ball number is set to 3 or less. When the ball number at the time of use is 8 to 12, when used in a wound site, it can have an appropriate adhesive force that can follow the action of the skin. Further, when the ball number is less than 8, since the initial adhesive force is low, when it is used in the movable wound site, since the skin action cannot be followed, the problem of immediate peeling occurs, which is not preferable. Further, when it exceeds 12, when it is used in a wound site, the adhesion is too strong, and there is a possibility that skin irritation may occur, which is not preferable. On the other hand, if the ball number at the time of exchange is 3 or less, there is no pain during exchange or the adhesion of the damaged skin. If it exceeds 3, the adhesion is too high, and there is a possibility of pain or damage during skin exchange. Not suitable.

As the plastic film covering the surface of the hydrogel sheet, polyethylene, polypropylene, polyester, polyvinyl chloride or the like, such as enamel treatment, corona discharge treatment, uneven treatment, plasma treatment, or the like can be used.

The method for producing the hydrogel sheet of the present invention is not particularly limited, and it can be produced by a known production method. For example, a hydrogel sheet can be formed by coating a hydrogel composed of the above-described constitution on a support and coating a surface of the hydrogel with a plastic film.

Radiation sterilization, electron beam sterilization, ethylene oxide sterilization, etc., which are usually performed, may be performed as needed.

Example

The present invention will be more specifically described by way of examples and comparative examples, but the present invention is not limited to the examples.

Example 1

After dissolving 1.6 g of the carboxyvinyl polymer in an appropriate amount of purified water, 20 g of the D-sorbitol solution was added and mixed until homogeneous. Further, 0.3 g of polyacrylic acid, 1.2 g of tartaric acid, 20.7 g of concentrated glycerin, 3.5 g of sodium carboxymethylcellulose (Carmellose Sodium), 4 g of polyacrylic acid partial neutralizer, 0.1 g of phthalic anhydride, 1.5 g of castor oil, 0.07 g of dihydroxyaminoacetic acid aluminum acetate, 0.08 g of sodium ethylenediaminetetraacetate, an appropriate amount of purified water, and uniformly mixed to prepare a hydrogel. This hydrogel was coated on 20 μm urethane/25 g nylon elastomer/m ² , and the hydrogel sheet was formed by coating the surface of the gel with a polyester film.

Example 2

The hydrogel was prepared in the same manner as in Example 1 and applied to a support of 20 μm urethane/nylon knitted fabric, and the surface of the gel was coated with a polyester film to form a hydrogel. Glue sheet.

Example 3

After dissolving 0.5 g of phthalic anhydride in an appropriate amount of purified water, 1.0 g of urea, 0.08 g of sodium ethylenediaminetetraacetate, and 0.5 g of castor oil were added and mixed until homogeneous. Further, 15.0 g of a 20% aqueous solution of polyacrylic acid, 0.3 g of tartaric acid, 16.0 concentrated glycerin, 4.0 g of sodium carboxymethylcellulose (Carmellose Sodium), 5.0 g of a polyacrylic acid partial neutralized product, 0.06 g of Magnesium aluminum silicate, 0.02 g of dry aluminum hydroxide gel, and an appropriate amount of purified water were uniformly mixed to prepare a hydrogel. This hydrogel was coated on 20 μm urethane/25 g nylon elastomer/m ² , and the hydrogel sheet was formed by coating the surface of the gel with a polyester film.

Comparative Example 3: "DuoACTIVE ET" ConvaTec, hydrocolloid wound covering material

Comparative Example 4: "Opsite" Smith & Nephew, polyurethane wound coating material

Comparative Example 5: "Bugel" Nichiban, PVA hydrogel wound coating material

Comparative Example 6: "Tegaderm" 3M company, hydrocolloid coating material

Test example 1

Using the hydrogel sheets of Examples 1 to 3 and the wound coating materials obtained in Comparative Examples 1 to 5, the stretchability, moisture permeability, water absorbability, and adhesion were measured in accordance with the following test methods. The measurement values were measured three times each, and the average value was obtained. The results are shown in Table 2.

1) Flexibility test

The stretch test was carried out in accordance with the stretch fabric of the general fabric test method of JIS L1096.

Cut the test material into 2 × 6 cm, and mark 4 cm at intervals (L ₀ ). The outer side of the wire was fixed by a clip, and a fixed load of 100 g was applied, and the distance (L ₁ ) between the marks was measured, and the elongation was calculated from the following formula.

Elongation (%) = (L _{1 -} L ₀ ) / L ₀ × 100

L ₀ : the length of the original mark (4cm)

L ₁ : length between marks (cm) when a fixed load of 100 g is applied

2) moisture permeability test

The moisture permeability test was carried out in accordance with the cup method of JIS Z0208.

Put about 10ml of purified water in a glass container (inner diameter: 56mm, depth 11mm), cut the test material into a circular shape (test piece) with a diameter of 80mm, with the paste surface inside, covering the opening of the glass container, with paraffin The stretch film seals the end of the glass container and the weight (W ₀ ) is measured.

Subsequently, the mixture was placed in a thermo-hygrostat at 40 ° C to 75% for 24 hours, and the weight (W ₁ ) after cooling was accurately measured, and the moisture permeability was calculated from the following formula.

Moisture permeability (g/m ² ‧24h)=(W ₁ -W ₀ )×10000÷A

W ₀ : pre-test weight (g)

W ₁ : weight after test (g)

A: Area of the opening of the glass container (26.4 cm ² )

3) Water absorption test

Put about 10ml of physiological saline in a stainless steel container (inner diameter: 88mm, depth 15mm), cut the test material into 4 × 4cm (test piece), with the paste surface as the inner side, sealed in the container, and stored for 8 hours. . The weight (W ₀ ) of the test piece before being placed in the container and the weight (W ₁ ) of the test piece taken out after 8 hours were compared.

Absorption: W ₁ -W ₀

4) Adhesion test

The tester described in the Pharmaceutical Manufacturing Sales and Marketing Guide 2005 (Approval of Manufacturing and Sales of Pharmaceuticals, Part IV, Adhesive Test, Chapter 1 Adhesion Test) is placed on the inclined surface at 30 degrees to the horizontal with the adhesive surface of the test preparation facing upward. Cover the upper 10 cm and the lower 15 cm with appropriate paper, and keep a 5 cm adhesive surface in the center.

A series of solder balls having a diameter of 3.2 mm to 34.9 mm were rolled from the inclined surface, and the number of balls stopped at the center adhesive surface for 5 seconds or more was measured.

This was used to evaluate the preparation before water absorption and after 8 hours of water absorption.

Test example 2

The moisture permeability of the supports used in Examples 1 to 3 and Comparative Examples 1 and 2 was measured by the calcium chloride method (A-1 method, 40 ° C - 90% RH) according to the moisture permeability test method of JIS L1099 fiber product. as shown in Table 3.

Test Example 3

The hydrogel sheets of Examples 1 to 3 and the wound coating materials obtained in Comparative Examples 1, 3, and 4 were attached to a wet sponge. A stainless steel container in which the sponge was circulated at 37 ° C in warm water. Further, a temperature and humidity sensor was sandwiched between the hydrogel sheet or the wound covering material and the sponge, and the temperature and humidity of the attached portion were measured to change to 60 minutes after the start, and then measured to 24 hours. The results are shown in Figures 1 and 2.

Test Example 4

The hydrogel sheets of Examples 1 to 3 and the wound coating materials obtained in Comparative Examples 3 to 5 of the commercial products were attached to the front wrist of 5 volunteers for 4 hours, and the skin adhesion and peeling were performed according to the following criteria. Assessment of pain.

1) Skin adhesion

For the skin adhesion, a three-stage evaluation of "not peeled off", "half peeled off", and "detached" was performed, and the results are shown in Table 4.

2) Pain during peeling

For the pain from skin peeling, a three-stage evaluation of "no pain at all", "no pain", and "pain" was performed, and the results are shown in Table 5.

Test Example 5

The wound hydrogel sheet obtained in Example 2 was attached to the layered defect portion after the formation of the suede on the back of the rat (n=3), and was peeled off after 8 hours of attachment, and the condition of the suede was removed to perform "coating." The material adheres to the affected area or remains more than 75% of the suede. "Strike force (visible pain action) or 50% or more of suede remaining" "can be easily peeled off and almost no suede residue" Evaluation. As a result, the sheet of Example 2 was attached for 8 hours, and no pain was reported, and peeling and the like were easily removed from the wound. The results are shown in Table 6 below.

Evaluation benchmark

1: It can be easily peeled off and almost no suede remains.

2: Forced when peeling (visible pain action) or more than 50% residual suede

3: The coated material adheres to the affected area or more than 75% of the suede remains.

When it is attached to the dried suede for 8 hours, the suede is softened, and the peeling agent is simply peeled off together.

The state of the wound before the administration of the suede and the peeling before the administration in Test Example 5, and the state of the hydrogel of Example 2 after the peeling are shown in Figs. 3, 4 and 5.

Test Example 6

In the wounds of P. aeruginosa infected in 24 mice, the hydrogel sheets of Example 1 and the wound coating materials obtained in Comparative Example 6 of the commercial product were exchanged every 48 hours, and the bacteria in the tissues after 5 days of injury. The number, wound contraction rate, and epithelial elongation were evaluated. The result is to prevent the wounds from being damaged by healthy skin and to prevent the wound from becoming refractory by reducing the number of bacteria in the infected wounds and the ultimate bacteria state. Furthermore, it is considered that wound healing can be promoted by adjusting the wound healing environment.

1) Number of bacteria in the tissue

After taking the affected tissue and measuring the weight, the bacteria were cultured and the number of bacteria was measured.

As a result, as shown in Fig. 6, in Comparative Example 1, the number of bacteria was significantly reduced as compared with Comparative Example 6, and it was considered to be effective for wounds in infected wounds and in the state of ultimate infection.

2) wound contraction rate

The distance between the epidermal wound margins of the affected area was measured, and the wound contraction rate was calculated from the following formula.

Wound contraction rate (%) = distance between the epidermal wound edge gap / distance between the wound edges of the hair follicle × 100

As a result, as shown in Fig. 7, in Example 1, compared with Comparative Example 6, it was considered that the wound area was shrunk, and it was considered that the wound healing was promoted.

3) Epithelial elongation

The distance from the wound edge hair follicle to the edge of the epidermal wound was measured to determine the epithelial elongation.

As a result, as shown in Fig. 8, in Example 1, compared with Comparative Example 6, it was considered that the epithelial elongation was more, and it was considered that the wound healing was promoted.

4) The macerated area of the surrounding skin

The area of skin maceration around the wound on the 3rd and 5th day of the wound was measured.

As a result, as shown in Fig. 9, in Comparative Example 6, the skin was gradually softened as compared with Example 1, and it was considered that the skin's macerated area was significantly different. Further, in Comparative Example 1, as compared with the decrease in the dip area as time elapsed, the softened area of Comparative Example 4 increased. From this, it is considered that Example 1 prevents exudation from the wound surface by the vertical direction, thereby preventing damage to healthy skin around the wound due to maceration, and at the same time reducing the risk of infection.

Industrial use

The main use of the wound hydrogel sheet of the present invention is to gently remove the wounded molting or necrotic tissue having ecdy or necrotic tissue, gently remove the bacterial biofilm or the wound-infected bacteria (antibacterial action), and By expelling the exudate from the wound surface in a vertical direction, the healthy skin containing the wound edge is not softened, maintaining a proper moist environment, maintaining a proper moist environment, and reaping the wound bed, thereby establishing a wound that causes the wound to be cured. Management, effective for trauma treatment of wounds or fresh trauma, surgical trauma, hot soup and acne exudate.

[Fig. 1] shows a local humidity change (1 hour).

[Fig. 2] shows a local humidity change (24 hours).

Fig. 3 is a view showing a state of rat skin before administration of a hydrogel sheet.

Fig. 4 shows the state of the wound portion of the rat after the hydrogel sheet was peeled off.

Fig. 5 shows the state of the hydrogel sheet of Example 2 after peeling.

Fig. 6 shows the number of bacteria in mouse wound tissue.

Fig. 7 shows the rate of wound contraction.

[Fig. 8] shows epithelial elongation.

[Fig. 9] shows the macerated area of the surrounding skin.

Claims (3)

A hydrogel sheet is used as a wound bed preparation, the wound bed environment is adjusted to remove a biofilm formed by bacteria in the skin wound, and the hydrogel sheet will contain a water-soluble polymer, The hydrogel of glycerin and water is coated on a two-layer laminated film, and the moisture permeability thereof is 200-2000 (g/m ² /24h), and the water-soluble polymer is selected from the group consisting of gelatin and hydrolyzed gelatin. Polyacrylic acid, sodium polyacrylate, polyacrylic acid partial neutralizer, polyacrylic acid starch, polyvinyl alcohol, polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, methyl fiber Carbelliose Sodium, carboxyvinyl polymer, methoxyethylene maleic anhydride copolymer, N-ethylene acetamide copolymer, Xanthan Gum and gum arabic One or a combination of two or more water-soluble polymers in the group, and the two-layered laminated film is formed of a polyurethane film and a hydrophobic fiber. A hydrogel sheet for use as a wound bed environment adjustment, the wound bed environment being adjusted to remove bacteria from the infected wound and/or to remove bacteria from the wound that is predicted to be infected and/or to inhibit bacterial growth and development, and the hydrogel sheet A hydrogel containing a water-soluble polymer, glycerin, and water is coated on a two-layer laminated film, and has a moisture permeability of 200 to 2000 (g/m ² /24h). Selected from gelatin, hydrolyzed gelatin, polyacrylic acid, sodium polyacrylate, polyacrylic acid partial neutralizer, polyacrylic acid starch, polyvinyl alcohol, polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxy Ethylcellulose, methylcellulose, Carmellose Sodium, carboxyvinyl polymer, methoxyethylene maleic anhydride copolymer, N-vinylacetamide copolymer, xanthan gum ( Xanthan Gum) and a water-soluble polymer in which one or more types are combined in a group of gum arabic, and the two-layered film is made of a polyurethane film and a hydrophobic fiber. A hydrogel sheet is used for the adjustment of a wound bed environment, the wound bed environment is adjusted to remove the skin of the skin wound, and the hydrogel sheet is coated with a hydrogel containing a water-soluble polymer, glycerin and water. It is composed of a 2-layer laminated film and has a moisture permeability of 200 to 2000 (g/m ² /24h). The water-soluble polymer is selected from the group consisting of gelatin, hydrolyzed gelatin, polyacrylic acid, sodium polyacrylate, and polyacrylic acid. Part of the neutralizer, polyacrylic acid starch, polyvinyl alcohol, polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, methyl cellulose, sodium carboxymethyl cellulose ( One or more of Carmellose Sodium), carboxyvinyl polymer, methoxyethylene maleic anhydride copolymer, N-vinylacetamide copolymer, Xanthan Gum, and gum arabic The water-soluble polymer is combined, and the two-layer laminated film is formed of a polyurethane film and a hydrophobic fiber.